PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 6 AND 25]
Drugs Which May Be Used By Qualified Optometrists; Schedules of Controlled Substances
[27 Pa.B. 1939] The Department of Health (Department), Bureau of Community Program Standards, proposes to amend § 6.1 (relating to drugs which may be used by qualified optometrists) by adding Rev-Eyes (Dapriprazole HCL) to the list of drugs which optometrists may use in the course of their practice.
The Department also proposes to amend the schedules of controlled substances in § 25.72 (relating to schedules of controlled substances). The proposed amendment under this section will reschedule one substance from Schedule I to Schedule II and add three previously unscheduled substances to Schedule I of the controlled substances list. The proposals are set forth in Annex A.
A. Statutory Authority
The amendment to the list of drugs which optometrists may use in the course of their practice is proposed under section 2 of the Optometric Practice and Licensure Act (OPL act) (63 P. S. § 244.2). The amendments to the schedules of controlled substances are proposed under sections 103 and 104 of The Controlled Substance, Drug, Device and Cosmetic Act (CSDDC act) (35 P. S. §§ 780-103 and 780-104). Both amendments are also proposed under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).
B. Purpose of the Amendments
Chapter 6 (relating to drugs which may be used by qualified optometrists)
Under the OPL act (63 P. S. §§ 244.1--244.12), optometrists who are certified by the State Board of Optometry to do so, may prescribe and administer certain drugs approved by the Secretary of Health (Secretary). The Department has approved a request from the State Board of Optometry to add Rev-Eyes (Dapiprazole HCL) to the list of approved drugs.
Chapter 25 (relating to controlled substances, drugs, devices and cosmetics)
The CSDDC act (35 P. S. §§ 780-101--780-144) recognizes the fact that there is a need to control substances which have potential for abuse while also recognizing that some of those substances have medical uses. The CSDDC act provides for a system of five schedules of controlled substances as a means of grouping potentially dangerous substances based on their differing potentials for abuse and on their potential for medical use. Penalties for illegal use of the controlled substances vary according to the schedule on which the substance is listed. The health and safety of the public is protected by having a substance placed on the proper schedule. Additionally, proper scheduling ensures appropriate enforcement when a substance is abused or otherwise used illegally.
The CSDDC act requires that a controlled substance be placed in Schedule I when there is : (1) a high potential for abuse; (2) no currently accepted medical use in the United States; and (3) a lack of accepted safety for use under medical supervision. A controlled substance is placed in Schedule II when there is : (1) a high potential for abuse; (2) currently accepted medical use in the United States or currently accepted medical use with severe restrictions; and (3) abuse may lead to severe psychic or physical dependence.
The amendments reschedule Levo-Alpha-Acetyl-Methodol (LAAM), previously listed in Schedule I of the schedules of controlled substances, to Schedule II. They further list Methcathinone, 4 Bromo 2, 5 Dimethoxyphenethylamine, and Dimethylamphetamine, all previously unscheduled substances, in Schedule I.
In proposing these amendments to the schedules of controlled substances, the Department is following the lead of the Federal Drug Enforcement Administration (DEA) which has previously scheduled all four substances as proposed herein.
C. Requirements of the Amendments
Rev-Eyes (Dapiprazole HCL)
The Secretary, upon the advice from the Drug, Device and Cosmetic Board, proposes to add the ophthalmic use only product Rev-Eyes (Dapiprazole HCL) to the approved drug products in § 6.1(a)(2). Rev-Eyes (Dapiprazole HCL) is a drug that reverses pupillary dilation (pupil enlargement) and partially reduces cyclopbegia (paralysis of focusing muscle), two effects of diagnostic eyedrops used in routine eye examinations. The reversal of these effects permits the patient to leave the doctor's office with less light sensitivity and improved visual performance.
Levo-Alpha-Acetyl-Methodol (LAAM)
The Secretary, upon the advice of the Drug, Device and Cosmetic Board, finds that placing the Schedule I narcotic known as Levo-Alpha-Acetyl-Methodol (LAAM) into Schedule II will make it available as an alternative to methadone in substance abuse treatment facilities in this Commonwealth. In 1993, the DEA transferred LAAM from Schedule I into Schedule II of the Federal Controlled Substances Act.
LAAM is a synthetic opiate developed in 1948 and clinically tested for treatment of opiate dependence since 1968. LAAM's primary advantage over methadone, the current approved drug for maintenance treatment, is its ability to relieve and prevent opiate withdrawal symptoms in addicts for up to 72 hours. Due to its long duration of action, the frequency of visits to a clinic can be reduced from daily to three times weekly even for patients just entering treatment. In general, addicts find participation in treatment more acceptable and return to the clinic more regularly. This is especially true for those addicts trying to engage in work, education or rehabilitation activities outside of the clinic, because travel time and effort is greatly reduced.
In addition, researchers found that LAAM offers the patient a smoother, sustained drug effect. Oral consumption even during the period of escalating doses did not produce excessive sedation or subjective euphoria. Researchers also emphasize that LAAM is less likely to be a reinforcer of daily drug taking behavior than methadone since a three times weekly dosage schedule frees the patient from the daily necessity of engaging in drug seeking and drug taking behavior.
Facilities utilizing LAAM for treatment of narcotic addiction will be subject to compliance with the requirements of the Narcotic Addict Treatment Act of 1974 (Pub. L. 93-281), and numerous regulations, both State and Federal, concerning narcotic treatment programs. The Department's Division of Drug and Alcohol Program Licensing currently inspects narcotic treatment facilities twice per year for compliance with these regulations.
Methcathinone HCL, 4 Bromo 2, 5 Dimethoxyphenethylamine and Dimethylamphetamine
In addition, the Secretary, upon the advice of the Drug, Device and Cosmetic Board is proposing the placement of Methcathinone HCL; 4 Bromo 2, 5 Dimethoxyphenethylamine; and Dimethylamphetamine into Schedule I of the controlled substances listing.
Methcathinone HCL
Methcathinone HCL is produced for street distribution in clandestine laboratories. There are no indications of current medical use of Methcathinone HCL in or outside of the United States. It has a high potential for abuse and is administered by nasal insufflation, oral ingestion, intravenous injection and smoking. Methcathinone HCL produces pharmacological effects and appears to have an abuse potential similar to that of amphetamines. It is usually sold as itself under street names of ''CAT'' and ''GOOB.'' In 1993, the DEA placed Methcathinone HCL into Schedule I of the Federal Controlled Substances Act (21 U. S.C.A. § 823).
4 Bromo 2, 5 Dimethoxyphenethylamine
4 Bromo 2, 5 Dimethoxyphenethylamine has been represented as 3, 4 Methylenedioxy Methamphetamine (MDMA) and has been sold in sugar cubes as LSD. More recently, it has been promoted as an aphrodisiac and distributed under the product name of NEXUS whose purported active ingredient is brominated cathinine. It is produced for street distribution in clandestine laboratories and has no known medical use. In 1994, the DEA placed this drug into Schedule I of the Federal Controlled Substances Act.
Dimethylamphetamine
Dimethylamphetamine is a drug which produces a significant central nervous system stimulant. Dimethylamphetamine is routinely sold on the street as methamphetamine or speed and is produced in clandestine laboratories. There are no know medical uses for this drug. In 1990, the DEA placed Dimethylamphetamine into Schedule I of the Federal Controlled Substances Act.
D. Who is Affected by the Proposed Amendments
The proposed amendment rescheduling LAAM will impact mostly on existing narcotic treatment programs in this Commonwealth. They will be afforded the use of an alternative to methadone. Facilities utilizing LAAM will be required to comply with Federal regulations at 21 CFR Parts 291.501 and 291.505, pertaining to the use of narcotic drugs in the treatment of addiction.
The amendment pertaining to Rev-Eyes (Dapiprazole HCL) will affect optometrists who will have the drug Rev-Eyes (Dapiprazole HCL) available for use on their approved drug products listing.
E. Cost and Paperwork Estimates
The proposal to the schedules of controlled substances will have no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public because a system already exists for the handling of controlled substances. Similarly, the proposal will not increase paperwork, since a paperwork system is already in place and will not measurably change with the addition of more substances.
The addition of Rev-Eyes (Dapiprazole HCL) to the list of approved drugs under the OPL act will not result in additional costs or paperwork.
F. Effective Date/Sunset Date
The amendments will be effective immediately upon final adoption. These regulations are continually monitored and updated as needed. Therefore, no sunset date has been set.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 9, 1997, the Department submitted a copy of the proposed amendments, to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendments, it will notify the Department within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the amendments, by the Department, the General Assembly and the Governor of objections raised.
H. Contact Person
Interested persons are invited to submit all comments, suggestions or objections regarding the proposal to John C. Hair, Director, Bureau of Community Program Standards, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-8665, within 30 days of publication of this notice in the Pennsylvania Bulletin. If you are a person with a disability, comments, suggestions or objections regarding the proposed amendments may also be submitted to John Hair in alternative formats, such as by audio tape, braille or by using TDD: (717) 783-6514. If you are a person with a disability and require an alternative format of this document (that is, large print, audio tape, braille) please contact John Hair so that he may make the necessary arrangements.
DANIEL F. HOFFMANN,
SecretaryFiscal Note: 10-144. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART I. GENERAL HEALTH
CHAPTER 6. DRUGS WHICH MAY BE USED BY QUALIFIED OPTOMETRISTS § 6.1. Approved drugs.
(a) Optometrists who are appropriately qualified under the Optometric Practice and Licensure Act (63 P. S. §§ 244.1--244.12) are permitted to utilize the following drugs in their practice of optometry:
* * * * * (2) Miotics. Miotics shall conform with the following:
* * * * * (iv) Dapiprazole HCL.
* * * * *
PART III. PREVENTION OF DISEASES
CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
SCHEDULES OF CONTROLLED SUBSTANCES § 25.72. Schedules of controlled substances.
* * * * * (b) Schedule I. In determining that a substance comes within this schedule, the Secretary will find: a high potential for abuse; no currently accepted medical use in the United States; and a lack of accepted safety for use under medical supervision. The following controlled substances are included in this schedule:
(1) The following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted whenever the existence of the isomers, esters, ethers, and salts is possible within the specific chemical designation:
(i) [Acetylmethadol] (Reserved).
* * * * * (3) A material, compound, mixture or preparation which contains any quantity of the following hallucinogenic substances, their salts, isomers, and salts of isomers, unless specifically excepted, whenever the existence of the salts, isomers, and salts of isomers is possible within the specific chemical designation:
* * * * * (xx) 4 Bromo 2, 5 Dimethoxyphenethylamine.
* * * * * (6) Unless specifically excepted or unless listed in another schedule, a material, compound, mixture or preparation which contains any quantity of the following substances including the salts, isomers and salts of isomers:
* * * * * (xxviii) Methcathinone HCL.
(xxix) Dimethylamphetamine.
(c) Schedule II. In determining that a substance comes within this schedule, the Secretary will find: a high potential for abuse; currently accepted medical use in the United States; or currently accepted medical use with severe restrictions and abuse may lead to severe psychic or physical dependence. The following controlled substances are included in this schedule:
* * * * * (2) The following opiates, including their isomers, esters, ethers, salts and salts of isomers, esters and ethers, of any quantity, unless specifically excepted or listed in another schedule, whenever the existence of the isomers, esters, ethers and salts is possible within the specific chemical designation:
* * * * * (xxvi) Levo-Alpha Acetyl-Methodol
* * * * *
[Pa.B. Doc. No. 97-592. Filed for public inspection April 18, 1997, 9:00 a.m.]
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